JP5538420B2 - Haptic device for intraocular lens - Google Patents

Haptic device for intraocular lens Download PDF

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JP5538420B2
JP5538420B2 JP2011538692A JP2011538692A JP5538420B2 JP 5538420 B2 JP5538420 B2 JP 5538420B2 JP 2011538692 A JP2011538692 A JP 2011538692A JP 2011538692 A JP2011538692 A JP 2011538692A JP 5538420 B2 JP5538420 B2 JP 5538420B2
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haptic
lens
eye
ring
sac
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JP2012509751A (en
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キヤラハン,ウエイン・ビー
コツク,ポール・エス
ヘイズ,アナ・エス
ケラン,ロバート・イー
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アニユー・オプテイクス・インコーポレイテツド
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Priority to US11808508P priority Critical
Priority to US61/118,085 priority
Priority to US15778109P priority
Priority to US61/157,781 priority
Priority to US61/184,655 priority
Priority to US18465509P priority
Priority to PCT/US2009/065960 priority patent/WO2010062976A1/en
Application filed by アニユー・オプテイクス・インコーポレイテツド filed Critical アニユー・オプテイクス・インコーポレイテツド
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2002/1681Intraocular lenses having supporting structure for lens, e.g. haptics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2002/1681Intraocular lenses having supporting structure for lens, e.g. haptics
    • A61F2002/1682Intraocular lenses having supporting structure for lens, e.g. haptics having mechanical force transfer mechanism to the lens, e.g. for accommodating lenses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2002/1681Intraocular lenses having supporting structure for lens, e.g. haptics
    • A61F2002/169Surrounding optic

Description

  This application is a US Provisional Application No. 61 / 118,085 filed Nov. 26, 2008, of the same title, each of which is incorporated herein by reference in its entirety. Claims priority to US Provisional Application No. 61 / 157,781 filed on the 5th and US Provisional Application No. 61 / 184,655 filed on June 5, 2009 of the same title To do.

  The present invention is directed to a haptic device for an intraocular lens that provides improved comfort and performance to a patient. In particular, the present invention is directed to a haptic device and design that includes an injector for inserting an intraocular lens without rotating the lens, and to a method of performing the insertion. In particular, the present invention, with various repetitive applications of the present invention, provides an appropriate degree of focus flexibility or perspective adjustment when used with single focus optics, and in certain instances surgery. Designed to alleviate the onset of later conditions, specifically post-poster cataractation.

  An intraocular lens (IOL) is an implanted lens in the eye that usually replaces an existing lens as a form of refractive surgery for the lens to become totally clouded by cataracts or to change the optical capabilities of the eye. Replace. The entire device typically includes a small plastic lens with plastic side posts, called haptics, to hold the lens in place inside the capsular bag inside the eye. The haptic also forms a means for attaching the lens to another part of the eye, including the front corner or groove, the iris, and the posterior chamber ciliary groove. IOLs have traditionally been made of a non-bent material (eg PMMA), but this material has been largely replaced by the use of flexible materials. Most IOLs fitted today are fixed single focus lenses that are tailored to distance vision. However, other types, for example, multifocal IOLs that provide patients with multifocal vision at long distances and reading distances, toric lenses IOLs to correct astigmatism, and indications that provide limited vision accommodation to patients IOL can be used.

  Intraocular lenses have been used since 1999 to correct larger errors in myopic (near visible), hyperopic (far visible), and astigmatic eyes. This type of IOL is also called a PIOL (phakic intraocular lens) and the lens is not removed. More generally, aphakic IOLs (ie, not PIOLs) are currently used for vision correction errors (especially substantially hyperopia) and are implanted by clear lens extraction and replacement (CLEAR) surgery. During CLEAR, the lens is removed and the IOL replaces the lens in a procedure very similar to cataract surgery. Both CLEAR and cataract surgery involve lens replacement and local anesthesia, both lasting approximately 30 minutes, both requiring a small incision in the eye for lens insertion. Patients recover from CLEAR surgery 1 to 7 days after surgery. During this period, the patient should avoid strenuous exercise or any activity that greatly increases blood pressure. In order to monitor the IOL graft, the patient should also visit the patient's ophthalmologist regularly for several months. CLEAR has a 90% success rate (risks include wound leakage, infection, inflammation, and astigmatism). CLEAR can only be performed on patients over 40 years of age. This is to ensure that eye growth that disturbs the IOL lens does not occur after surgery.

  Once implanted, the IOL lens has three major advantages. First, IOL lenses replace LASIK, a form of eye surgery that does not work for people with serious visual problems. Second, effective IOL implantation may eliminate the need for glasses or contact lenses after surgery. Third, the cataract does not recur when the lens is removed. The drawback is that the ability of the eye to change focus (perspective accommodation) may be reduced or eliminated depending on the type of lens embedded.

  Although significant progress has been made in the optical properties of aphakic lenses, most lenses made today have an overall optical thickness of 1 mm or more at the central optical focus (see, for example, US Pat. No. 4,363). 142). In the late 1990s, two patents were filed for lens optics that were considerably thinner than the lens patent referred to above, and subsequently entered into force (US Pat. Nos. 6,096,077 and 6,224). No. 628). Although improved, the extreme thickness of lenses manufactured in accordance with US Pat. No. 6,096,077 caused some small distortion of the optical components when entering the eye, whereas , 628, manufactured in large quantities from shaped silicone, did not provide the desired visual acuity.

  In general, the lens separates aqueous humor from the vitreous. The iris separates the cornea of the eye or the area between the front and the lens into the anterior and posterior chambers. The lens itself is contained within a membrane known as the capsule or capsular bag. When the lens is removed from the eye, the sac may also be removed (endocapsulectomy), or the front part of the sac may be removed with the lens leaving the posterior part of the sac intact (the sac Ectomy), often leaving a small folded part or flap from the front part of the sac. In intraocular implantation, the lens of the artificial lens or prosthesis may be inserted into the anterior chamber, posterior chamber, or capsular bag. The artificial lens is usually fixedly attached to the interior of the eye by stitching to the iris or by some support means or arm attached to the lens. In either case, the locking mechanism is classified as a haptic.

  In order to avoid the need for clips or sutures to secure the lens to the iris, some intraocular lenses designed for implantation in the anterior chamber feature a haptic with a lens-supporting foot. And The lens works. However, making the lens sized to fit the eyes was important to avoid complications. The lenses were made from 11.5 mm to 14 mm in lengths of 0.5 mm and the leg thickness was about 250 microns.

  Various lenses have been developed that provide up to four point support for the lens. Support structures for these haptics are often coupled to the lens body so that the support structure does not deviate freely from the lens body, and thus there is no room for irritation to the part of the eye that contacts the support structure. Various shapes and geometries for lens support elements, ie haptics, have been disclosed and described (US Pat. No. 4,254,510, US Pat. No. 4,363,143, US Pat. US Pat. No. 4,480,340, US Pat. No. 4,504,981, US Pat. No. 4,536,895, US Pat. No. 4,575,374, US Pat. 581,033, US Pat. No. 4,629,460, US Pat. No. 4,676,792, US Pat. No. 4,701,181, US Pat. No. 4,778, No. 464, U.S. Pat. No. 4,787,902, U.S. Pat. Reissue Patent No. 33,039, U.S. Pat. No. 4,872,876, U.S. Pat. No. 5,047,052. Statement, Country Pat. No. 2,165,456).

  Despite progress, problems remain with intraocular implantation. For example, when an intraocular lens is inserted into the eye, an incision is made in the cornea or sclera. The incision can change the thickness of the cornea, resulting in an uneven surface that can lead to astigmatism. Inserting a rigid lens through an incision requires a large enough incision (typically at least 6 mm) to fit the rigid lens, even with compressible haptics, and with the incision, complications such as infection, tearing of ocular tissue , And with an increased risk of retinal detachment. A flexible intraocular lens made from polymethyl methacrylate (eg, “PMMA”), polysulfone, silicone, or hydrogel may be inserted through a smaller incision of about 4 mm.

  It is preferred that the intraocular lens can be inserted through a small incision. U.S. Pat. No. 4,451,938 describes two lens bodies so that each piece is inserted separately through an incision and then joined by dowel after insertion into the eye. It shows an intraocular lens made of fragments. U.S. Pat. No. 4,769,035 discloses a folding lens that may be inserted through an incision about 3.5 mm long.

  When the intraocular lens is inserted into the anterior chamber of the eye, the haptic leg, ie the lens support element, is generally in the scleral groove, and the iris and ciliary muscles sclera at the corner of the anterior chamber. A depression is housed in front of the scleral spur to be joined. The scleral grooves are intersected by trabecular tissue located in the Fontana gap. The anterior chamber of the eye is secreted by the aqueous humor, i.e. ciliary process, from the posterior chamber through the pupil to the anterior chamber and from the corner of the anterior chamber where fluid passes into the Fontana gap. The venous Schlemm's canal is filled with fluid that passes to the comb-like villi that are filtered. The lens should be positioned so that fluid flow through the trabecular tissue is not obstructed, otherwise glaucoma may occur.

  As the haptic leg of the anterior chamber lens remains in the scleral groove, fluid flow is blocked where the leg contacts the trabecular tissue. Therefore, it is desirable to reduce the amount of surface area of the haptic leg that contacts the trabecular tissue. At the same time, the haptic leg has a height sufficient to prevent adhesive tissue or Cinecia from growing around the leg and anchoring the haptic leg to the iris or cornea. The trabecular opening is about 200 microns and the haptic legs of conventional intraocular lenses are usually on the order of 175 to 200 microns, so long as the leg is in contact with tissue, the trabecular opening Effectively shield.

  Another lens placed in the posterior chamber may attach to the ciliary groove or be placed in the equator of the capsular bag. For haptics that adhere to the ciliary groove, proper dimensioning is essential to ensure proper tethering. With haptics that attach to the sac of the sac, recent scientific knowledge also demonstrates the need for proper sizing as the haptic must properly place the lens in the sac. If the haptic is too short for the sac, the lens may be dislodged or rotated in the eye, which may require additional surgery to heal, and may cause intraocular trauma It is an event. Furthermore, a haptic that is too short for the sac does not allow the lens to provide the patient with any desired or specified focus flexibility (ie accommodation). If the haptic is too long for the sac, the lens may bend backwards or forwards at a larger angle than specified, and in the former case, it greatly reduces the intensity of vision at long distances and reverse perspective The adjustment is compromised and in the latter case, pressure is applied to the iris to reduce focus flexibility.

  US Pat. Nos. 5,258,025 and 5,480,428 describe lenses that are surrounded by a sheet-like “positioner”, the positioner being at the four corners of the positioner or at the positioner. With a protrusion called a “support element” that continuously supports the element, the support element having a length of 0.3 mm and a thickness of 0.01 mm to 0.05 mm (No. 5,258,025) 7 "a and 7" b of FIG. 3 of the patent, 18 of the 5,480,428 patent). However, the lens is intended for implantation in the posterior chamber, and the lens of US Pat. No. 5,480,428 is short enough to actually “float”. Furthermore, the sheet-like properties of the positioner prevent the leg's unique bias in response to the force applied by the eye.

  Further, depending on the lens structure, the lens may exert a greater or lesser degree of force on the haptic leg when the lens is compressed. Since the amount of pressure for a given surface area is proportional to the force, the amount of force applied on the haptic leg can be reduced or dispersed to reduce the force applied by the leg on the trabecular tissue. desirable. This goal is achieved by mounting a haptic arm on the end of the flexible support bar in a cantilever manner, the support bar being offset from the lens body by a mandrel.

  The act of surgically removing the native lens and replacing the native lens with any design of intraocular lens, the patient's ability to see clearly over an extended period of time, a focus that can be provided to the patient It causes certain other possible situations that can have a profound impact on the range of accommodation and the effective placement of the replacement lens in the eye. These situations generally occur in most cases, but may be mitigated using the inventive lens and haptic design. Specifically, the ophthalmologist recognized that the capsular bag tends to atrophy over time. This tendency makes the replacement lens rarely occupy the entire capsular bag, and most lenses tend to flatten the sac, thus allowing the anterior and posterior surfaces of the sac to adhere together. In part, it causes sac atrophy, hardening, and adhesion. All of this necessarily reduces the effectiveness of any lens that needs to provide focus adjustment. It is possible that increased aqueous humor circulation can maintain the flexibility of the natural capsular bag, and preventing contact between the capsular surfaces should prevent sac attachment.

  There were surgeons who claimed to use a sac retention ring to prevent sac atrophy. However, these rings are placed in the lens equator and are generally used only during surgical procedures, but do not allow the ciliary body to affect the dimensions of the lens to provide for focus adjustment. . Thus, although the sac retention ring may be effective when used with a non-perspective lens, the value of the sac retention ring with an expensive lens that requires accommodation is questionable.

  In some cases, post-surgical attachment may occur between the capsular bag and the haptic of the intraocular replacement lens. If sufficiently conspicuous, these attachments can reduce the focusing function of the lens.

  Secondary cataract (PCO) occurs in approximately 50% of cataract patients within 3 years after surgery. PCO is caused by the natural transfer of epithelial cells from the anterior lens capsule to the equator and thus to the posterior surface. When the epithelial cells reach the equator, they die, in the form of Elschnig's pearls, or in the form of fibroblasts that can attach to the sac and cause large fibroblasts, contraction, and lens clouding. Leave the protein to accumulate on the posterior capsule surface. If the PCO enters the optical range of the sac, vision is greatly impaired. The occurrence of PCO can be mitigated surgically using a Nd-YAG laser correction that opens a small hole in the posterior capsule that prevents the PCO from further importing. However, Nd-YAG laser capsulotomy also involves the risk of post-operative complications including possible invasion of vitreous into the sac, and should therefore be avoided if possible.

U.S. Pat. No. 4,363,142 US Pat. No. 6,096,077 US Pat. No. 6,224,628 U.S. Pat. No. 4,254,510 US Pat. No. 4,363,143 US Pat. No. 4,480,340 US Pat. No. 4,504,981 US Pat. No. 4,536,895 US Pat. No. 4,575,374 US Pat. No. 4,581,033 US Pat. No. 4,629,460 US Pat. No. 4,676,792 US Pat. No. 4,701,181 U.S. Pat. No. 4,778,464 US Pat. No. 4,787,902 US Reissue Patent 33,039 Specification U.S. Pat. No. 4,872,876 US Pat. No. 5,047,052 British Patent 2,165,456 U.S. Pat. No. 4,451,938 U.S. Pat. No. 4,769,035 US Pat. No. 5,258,025 US Pat. No. 5,480,428

  In the case of the haptic design of the present invention incorporated herein, the inventors may have the onset of PCO delayed or eliminated entirely by the use of an appropriate haptic design that prevents epithelial cell transfer. I am sure that. Specifically, 1) Designing an ultra-thin fixation plate, and making an ultra-thin fixation plate that fits tightly at the equator of the sac to the right size reduces epithelial cell transfer in the haptic attachment zone, and thus Intended to relieve the PCO, 2) a haptic design that keeps the sac open and prevents contact between the anterior and posterior surfaces reduces the onset of PCO by maintaining hydration of the sac 3) The quality of cataract or CLEAR surgery can help slow the PCO by continual lavage and polishing the posterior capsule, and 4) against the surface of the anterior capsule Placing either the sac equator to the surface of the posterior sac and some retaining ring in the sac can prevent epithelial cell transfer and congeal epithelial cells within the posterior sac optical zone. There is possible to prevent. In some cases, IOL designers have found some success in mitigating the onset of PCO by configuring the posterior surface of the lens to form a right angle with the posterior capsule at the junction of the lens. Specifically, this configuration can be applied to a lens that stays completely with respect to the posterior capsule and does not adjust the perspective. In another case, the IOL designer has confirmed that the surface quality of the haptic can have some impact on PCO import.

  The present invention overcomes the problems and drawbacks associated with current schemes and designs, provides not only a new haptic device and method for placing an intraocular lens in the eye, but also provides optimal focus flexibility and is common Providing a design for a specific function to alleviate post-operative problems.

  One embodiment of the present invention is directed to a haptic device that adheres to the side of the end of the lens at a distance from the center of the lens. Preferably, the haptic is preferably about a first haptic contact that divides the plane of the line passing through the center of the lens, preferably about 60 ° from the 12 o'clock position of the lens, and preferably about 12 o'clock of the lens. It has a second haptic contact that divides the plane of the line passing through the center of the lens at 300 °. Preferably, the haptic arm centerline is an extension of the plane passing through the lens at 60 ° and 300 °, the center being the center of the lens and extending so that the radius intersects a circle larger than the lens radius. Also preferably, the radially spaced ends connect to an arm that intersects the haptic outer diameter at an offset point parallel to the 12 o'clock plane of the lens.

  Preferably, the haptic is designed to fix the lens on each side of the end of the optic at an angle of 60 ° from the central meridian of the lens. The haptic arm extends outward from the optical connection and then curves back inward to provide a rigid arc of haptic material coaxial with the optical end of the lens and constant from such optical end. A band of haptic material that is connected at a distance of and provided in the kidney-shaped open portion between the lens and such haptic material. The haptic material is preferably flexible, so the haptic design should be haptic in the anterior / posterior plane to allow for proper lens placement in the eye without anterior-posterior displacement. Prepare for greater thickness. The end of the haptic may be rigid and the fixed part of the haptic is thinner or thicker than the band of material at the optical connection. In addition, the design of the haptic at the point of fixation of the haptic to the sac allows the anterior and posterior edges of the sac to be anchored to the haptic at such points, thus inhibiting epithelial cell transfer from the anterior sac to the posterior sac. , Thereby intended to be able to relieve subsequent cataracts. In another embodiment, the haptic arm is moderately arched to increase focus flexibility.

  Another embodiment of the invention is directed to a kidney-shaped haptic device with a rigid haptic end portion. Preferably, the stiff end portion is thinner than the rest of the haptic. The haptic may further include notches that are radially adjacent to the 12 o'clock position to allow for bending. The function of the haptics of the present invention is to anticipate natural capsular atrophy after surgery while maintaining both firm anchoring of the haptic at the equator of the sac and centering of the lens optics within the sac.

  Another embodiment of the invention is directed to a kidney-shaped haptic device with a rigid haptic end portion. Preferably, the rigid portion of the haptic is configured to extend forward to encounter the anterior capsule at a distance from the equator and to extend backward to also encounter the posterior capsule at a distance from the equator. The haptic may further include notches that are radially adjacent to the 12 o'clock position to allow for bending. The haptic also includes a series of small indentations at the inner radius of the front and / or rear legs that respond flexibly to not only ciliary movement but also to natural differences in sac size There is. The function of the haptic of the present invention is to alleviate the onset of capsular atrophy after natural surgery by holding the sac open at the equator. This should provide for enhanced circulation within the sac of an aqueous solution that may retain an appropriate level of hydration to preserve the sac flexibility. This may also reduce the tendency of the anterior and posterior sac to stick to each other, which occurs after general surgery using another haptic design. Another function of the haptics of the present invention is the natural flexion of the capsular bag in response to ciliary activity while maintaining both the tight attachment of the haptic to the sac and the centering of the lens optics within the sac. And providing an arrangement of haptic legs to respond to stretching.

  Another embodiment of the present invention has a haptic leg that includes some open portion between the haptic leg and the optic, and includes a ring that arcs forward and backward relative to the plane of the lens optic, As a result, the anterior ring contacts the anterior capsule at a distance from the lens equator, the posterior ring contacts the posterior capsule at a distance from the lens equator, the rings are connected to each other, and the ribbon and the ring are appropriate A haptic device connected to a framework that supports lens optics using struts that maintain proper spacing and provide for proper positioning of the lens within the capsule. The function of the anterior ring is to prevent the transfer of epithelial cells throughout the anterior sac, thus preventing these cells from maturing and reaching the equator of the sac. Another function of the anterior ring of the present invention is to respond to changes in the ciliary body in such a way that the forward movement of the lens optic inside the capsule can be adapted to near vision. . The function of the posterior ring retains an appropriate barrier between any pearls or fibroblasts that can develop over time and block the penetration of pearls or fibroblasts into the area behind the lens optic This is to protect the rear optic zone from the PCO. Another function of the posterior ring captures the physical forces on the ciliary body and works with the anterior ring, struts, and haptic ribbon to move the lens optics inside the sac to accommodate various stages of focus adjustment It is to be able to make it. Another function of the posterior ring with the anterior rings, struts, and ribbons is to maximize the natural circulation of the aqueous humor so as to maintain hydration of the capsular bag and the entire aqueous humor. This hydration may have the additional desirable effect of providing a mechanism by which consumed and suppressed epithelial cells can be swept away by aqueous humor and placed throughout the trabecular meshwork.

  Another embodiment of the haptic of the present invention is a rigid circular haptic that is preferably five cut arcuate channels extending from the front ring to the end of the optic. These channels allow the optic to fit and move without distortion and misalignment while the anterior and posterior haptic rings secure the lens in the center within the sac and keep the sac open. To do.

  Another embodiment of the invention is directed to a haptic design that functions using an injector for surgically injecting a lens and haptic into a patient's eye. Preferably the patient is a mammal, more preferably the mammal is a human. The injected haptic can be compressed to allow insertion into the eye. Preferably, the outer part of the haptic is compressed into a pointed shape that helps it move through the syringe and into the eye so that the flexible part is more in the front and back planes. Thick, allowing the haptic to bend for placement inside the eye without anterior / posterior movement. Also preferably, the adjacent distal tip of the rigid portion is attached to the bottom of the haptic portion to create an offset between the rigid portion of the haptic and the flexible portion. The distal end can remain at the equator of the sac when inserted into the eye that contained the native lens, and a zonule behind the eye remains against the sac. Once placed in the eye, the force generated by the movement of the ciliary process of the eye moves the ciliary band toward the prime meridian of the eye, which in turn is inherently Force can be transmitted through the sac containing the lens to the end of the rigid part of the haptic. Preferably, the haptic transmits the force to the end of the flexible portion of the haptic where the offset generates an upward rotational force along the haptic, which in turn can advance the lens forward within the eye . Also preferably, the tip of the adjacent end of the rigid portion is attached to the bottom of the haptic portion that creates an offset between the rigid portion of the haptic and the flexible portion. The distal end can remain against the anterior surface of the sac when inserted into the eye that contained the native lens and the posterior end remains against the posterior surface of the sac. Once placed in the eye, the force generated by the movement of the ciliary process of the eye can move the ciliary band towards the prime meridian of the eye, this time the ciliary small The band transmits force through the sac that contained the natural lens to the end of the haptic leg. The haptic can preferably transmit this force through a series of struts connecting the anterior ring to the posterior ring and to the end of the haptic's flexible portion, where the haptic's flexible portion: The offset creates a forward force along the haptic, which in turn advances the lens forward inside the eye.

  Another embodiment of the haptic of the present invention is to provide a series of strut mitigators that connect the anterior and posterior haptic rings so that the level of force applied to the lens is the desired degree of the lens inside the eye. It corresponds to the movement of the perspective adjustment.

  Another embodiment of the present invention is directed to a haptic of the present invention, further comprising a second haptic that is localized 180 ° from the first haptic when inserted into the eye. Preferably, the lens and haptic are in essentially the same anterior-posterior plane. When placed in the eye, forward movement of the lens creates the ability to see nearby objects from a single focal plane lens. When the lens is placed forward relative to the end of the haptic, the lens produces a positive cap, and when placed rearward relative to the end of the haptic, the lens creates a negative cap.

  Another embodiment of the invention is that the portion of the haptic is flexible and the ciliary band of the eye transmits the force to the rigid portion of the haptic that generates an upward force vector, Target an haptic that draws an arc when an upward force vector is inserted into the eye to a location that moves the lens optic forward. If the haptic is a small haptic at the point of contact between the equator and the haptic of the lens, the amount of space between the anterior and posterior surfaces of the native lens capsule can be reduced, allowing the surfaces to grow together Like that. In this case, the attached sac surface, and the end of the haptic, form an opening that is small enough to greatly reduce cell transfer from the equator region of the sac. If the haptic used has anterior and posterior rings, an appropriate amount of spacing between the anterior and posterior surfaces of the capsular bag will prevent the surfaces from growing together. Preferably, the angle of the negative lid and the angle of the radius between the prime meridian and the optical end are equal. Also preferably, the equal angles create a tangent line between the capsule that contained the native lens and the end of the lens optic. When inserted into the eye, tangential forces use the sac to seal the end of the lens and prevent cell transfer under the lens.

  Another embodiment of the present invention is that the optic stays behind in the sac for distance vision and the joint, bend, or extension moves the lens forward for near vision in response to ciliary movement. A haptic where a haptic portion is bent and connected to a connection portion so as to be moved is targeted. Preferably, the ring is attached to an arcuate joint or segment that remains on the anterior and / or posterior surface of the sac to maintain a distance between such anterior and posterior surfaces, thereby providing a continuous sac For natural hydration and natural fluid circulation in aqueous humor. Also preferably, such a ring substantially suppresses the epithelial cell transfer to the anterior capsule and the rapid increase of secondary cataract in the focal range of the lens.

  Another embodiment of the present invention comprises the steps of removing a native lens from a mammalian eye and inserting a lens comprising the haptic of the present invention into the mammalian eye. Intended for the method of fixing the lens inside.

  Another embodiment of the present invention is directed to a device, such as an insertion device, and a method for inserting a haptic into a lens envelope of a mammalian eye comprising the haptic of the present invention.

  Additional embodiments and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned from practice of the invention.

It is a top view of a lens provided with a haptic. Fig. 5 shows a sagittal view of a lens with a haptic. Ciliary projections for distance vision. Shows ciliary projections for near vision. 1 shows a lens with an arcuate haptic. It shows that the thin edge delays secondary cataract. The cross-sectional part of the haptic end is shown. Fig. 5 shows the region of the connection between the haptic and the lens that is magnified. Fig. 5 shows an enlarged area of connection between the haptic and the lens. FIG. 6 is a top view of a lens with a haptic that includes a curved ribbon to form a kidney shape. Shown is a sagittal view of a curved and opened haptic in a distance position. Fig. 6 shows a haptic sagittal view with a curved loop in the near vision adjustment position. FIG. 4 shows a second iteration of a curved ribbon (open loop) haptic in the far vision position. FIG. 4 shows a second iteration of a curved ribbon (open loop) haptic in the near vision adjustment position. Figure 3 shows a third iteration of an open loop haptic at a distance position. Fig. 5 shows a third iteration of an open loop haptic at the near vision adjustment position. Figure 2 shows a second iteration of an open loop kidney ribbon haptic. Fig. 4 shows a fourth iteration of a haptic at a distance position. Fig. 4 shows a fourth iteration of a haptic at the near vision position. FIG. 9 shows a fifth iteration of an open loop haptic with front and rear legs in the initial design specification. Fig. 5 shows a fifth iteration of an open loop haptic at a distance position. Fig. 7 shows a fifth open loop haptic in the near vision adjustment position. An open loop haptic design (kidney haptic) with full anterior and posterior rings is shown. A complete circular haptic with an arcuate groove is shown.

  A haptic device is used to secure the intraocular lens inside the lens capsule once the native lens has been surgically removed. The three specific design objectives of the haptic are i) to allow the lens to be implanted in the eye using a special syringe through an incision less than about 3 mm, ii) focus flexibility for the patient Allowing the lens to move inside the posterior chamber of the eye to provide, and iii) the weight of the lens replacement procedure currently occurring in approximately 50% of patients within 2 to 3 years after surgery Fixing the lens to the equator of the capsular bag in such a way as to minimize the risk of secondary cataract ("PCO"), which is a poor result. Intraocular lenses have now been successfully implanted for decades, but many haptic designs have helped relieve PCO and / or focus flexibility (or adjust the patient from far vision to near vision and need reading glasses) Does not produce the desired result of facilitating the ability to minimize sex.

  Haptic device design unexpectedly improves haptic device design and facilitates focus flexibility (or the ability of the patient to adjust from far vision to near vision and minimize the need for reading glasses) I also found. In one embodiment, the haptic of the present invention is preferably an attachment that may be any of polymethyl methacrylate, hydrophobic or hydrophilic acrylate, silicone, or a mixture of these materials (or the same material as the lens) The lens is fixed to the equator of the capsular bag using a rigid but very thin plate of the same material as the lens. The width of the plate is typically designed to extend beyond the portion of the lens envelope that closes after removal of the native lens (FIG. 7). Epithelial cells typically found on the anterior surface of the inner lens capsule can be transferred to the posterior surface if the epithelial cell pathway is not obstructed. The purpose of the haptic design of the present invention is to provide a tighter closure at the end of the haptic that inhibits continued transfection and growth of epithelial cells. In addition, the width and breadth of that portion of the haptic serves to prevent transfer of such epithelial cells through the anterior portion of the lens capsule and into the equator. Although this design may not completely eliminate the risk of PCO, this design substantially retards PCO growth.

  The second haptic device design will improve the PCO and facilitate focus flexibility (or the ability of the patient to adjust from far vision to near vision and minimize the need for reading glasses). I found it unexpectedly. In one embodiment, the haptic of the present invention is secured to the anterior sac using an arcuate anterior leg and between the anterior and posterior sac to provide for continued hydration of the capsular bag by aqueous humor fluid. Secured to the posterior sac using an arcuate posterior leg with the effect of holding space. The connection between the arcuate front leg and the arcuate rear leg is made by a series of struts, which may cause some easement to break into the leg and the front and back of the haptic While maintaining the desired distance between the legs of the lens and optimizing the accommodation force on the optical components of the lens of the invention while providing for proper fluid circulation between the posterior chamber of the sac and aqueous humor. Epithelial cells normally found on the anterior surface of the inner lens capsule can be transferred to the posterior surface if the epithelial cell pathway is not obstructed.

  In another embodiment, the haptic design has anterior and posterior haptic legs that include complete rings where the haptic design remains on the anterior and posterior sac, respectively, holding the entire sac open, It was surprisingly found that barriers were created on both the anterior and posterior sac surfaces to prevent transfer. In this embodiment, the haptic legs are connected by a series of struts with an open space between them to maintain a specified distance between the rings and provide for optimal fluid circulation around the lens of the present invention. In this embodiment, the anterior and posterior rings may also be configured to prevent the migration of epithelial cells throughout the anterior sac and the invasion of PCO into the optic zone of the posterior sac, thereby It provides the possibility for the patient to use an intraocular lens for a considerable period without adverse consequences. In this example, a relaxation material may be made in the struts to accommodate a smaller sac than the normal sac, and thus the lens despite possible sac size differences or changes over time. Prepare for stable light collection of optical components. In this embodiment, some cushioning material may also be made in the inner surfaces of the front and rear rings to provide for the responsiveness of the lens haptic to ciliary muscle stimulation.

  In another embodiment, the haptics of the present invention may be constructed primarily from a ribbon of the same material as the lens to be attached (as described herein). The open framework design of this part of the haptic allows the ciliary body movement to move the optics back and forth in the eye in almost the same way as a natural lens with minimal lateral or diagonal distortion. It is intended to hold the centered optical component facing the retina while responding. In a variation of this haptic design as described in FIG. 5, the arcuate portion of the haptic further facilitates focus flexibility and moves the lens optics forward when the patient focuses on a close object.

  In these embodiments, it is preferred that the overall dimensions of the lens, including both haptics and optical components, vary depending on the natural capsular measurements. The haptics vary in their individual adjustments, including the length of the ribbon haptics (2) and (3), as well as the dimensions of the rigid end portions of the haptics. In addition, haptics may be used for veterinary applications, and the overall haptic dimensions may be increased or decreased to fit the capsular bag of various animals.

  The following examples illustrate embodiments of the invention, but should not be viewed as limiting the scope of the invention.

Example A top view of an intraocular lens with a haptic device is depicted in FIG. 1 and a sagittal view is depicted in FIG. A haptic attachment (1) to the optic is shown with a ribbon-shaped haptic extension (2) in the plane through the center of the optic and the attachment point. The ribbon haptic arm intersects a circular plane that is larger than the radius of the optical component (3). The rigid end portion (4) of the haptic crosses the outer diameter of the lens at a point parallel to the plane passing through the 12 and 6 o'clock positions of the lens. The overall shape of the haptic resembles a kidney with a sharper curvature (5) than the lens optics make up part of the kidney. The rigid haptic end portion (6) is thinner than the ribbon-shaped portion (3).

  As depicted in FIG. 1, a ribbon haptic (8) exists between the rigid part (6) and the end of the extended arm (3). The ribbon-shaped part (8) of the haptic is shown in FIG. 2 on the rigid part (6) of the haptic. Also, along with the bottom, the ribbon haptic (8) adheres to the rigid haptic (6) along the edge (near the optical component) of the rigid part (6) of the haptic. FIG. 1 shows an indentation (9) split into a rigid haptic portion (6) that allows easy bending for deformation into the injector.

  As depicted in FIG. 3, the tip (10) of the lens haptic (4) remains against the equator of the sac held in place by the ciliary zonule (11). The ciliary band (11) is a hair-like structure that attaches to the natural lens and ciliary body and holds the natural lens in place. The ciliary band (11) also helps to change the shape of the native lens for near vision. FIG. 3 also shows a pouch (12) with the native lens removed, and an eye ciliary body that changes shape to allow the native lens to change shape to give near vision to the patient. Draw (13). The cornea (14) is the transparent part of the eye that refracts (bends) light. In tune with the natural lens, it is bent so that the light is focused on the retina. The eye iris (colored portion) (15), also depicted in FIG. 3, is used to measure the amount of light allowed into the eye.

  As depicted in FIG. 3, there is an intraocular lens in the far-sighted position in the eye (16), but in FIG. 4, the ciliary shape is such that the intraocular lens is in the near-sighted position (18) in the eye. The body (17) moves and changes shape to provide near vision.

  FIG. 5 depicts an arcuate haptic (19). As the ciliary body moves, a force is applied to the tip of the haptic and that force is transmitted into the arcuate haptic, which compresses the haptic and moves it forward.

  One embodiment of the haptic device and optical lens is depicted in FIG. 6, but the region of the haptic (AA), further outlined in FIGS. 7, 8, and 9, so that the PCO is mitigated Demonstrates that it is specifically designed. FIG. 6 addresses the circular formation depicted by the arc extension shown, attributed to the haptic plate, showing the approximation of the equator of the sac and the lens position within the sac.

  In FIG. 7, the cross-sectional portion of the haptic end is depicted. The front portion (20) of the native lens, the rear portion (21) of the native lens, and the thin rigid end portion (22) of the intraocular lens haptic are shown.

  FIG. 8 depicts the anterior and posterior portions of the native capsular bag as they grow together after surgery. In FIG. 9, the enlarged portion of FIG. 8 is depicted, indicating that the remaining tissue (24) surrounding the rigid end portion of the lens has been tightly spread. A small opening (25) remains, which prevents movement of cell growth through the opening. With a thick footplate, the opening is often large enough that there is little or no interference with cell transfer. Thus, the cells are placed between the intraocular lens and the posterior sac that makes the sac opaque and reduces the passage of light.

  Ribbon haptics provide for constant centering of the native mitigator and lens optics while ensuring sufficient push strength to provide focus adjustment by moving the optics forward and backward within the capsule. A top view of the haptic with the corners removed is shown in FIG. 10 for a continuous kidney shape whose width is less than the haptic depth. FIGS. 11 and 12 are sagittal views of such a lens haptic, with two corners, such as the knee and ankle, that respond to the bending and stretching ciliary muscle forces and thus move the lens optics. A haptic design that is structured as follows.

  As depicted in FIGS. 13 and 14, the innovative haptic provides additional flexibility and push to move the lens inside the eye to adjust to fit far vision and near vision 1 Contains one or more arcuate or arcuate segments. The dimensions of the arcuate segments may vary according to the purpose for which they are designed and the widths of the segments may be varied or matched, while the joints of the segments bend appropriately so that the length of the segments is the lens optics The segment depth may be configured to vary according to the stress calculation for that segment so that the required force can be applied to the part.

  As depicted in FIGS. 15 and 16, innovative haptics include knees, and the posterior legs of the haptics are designed to remain somewhat central than the junction of the anterior capsule and the knee-like part.

  FIG. 17 illustrates another embodiment of a kidney-shaped haptic, and FIGS. 18 and 19 demonstrate a sagittal view of such a haptic where the anterior haptic plate is curved forward toward the center of the eye. Configured. Although the posterior leg of the haptic stays against the posterior capsule at some point outside the contacts worthy of an anterior haptic comparison, the dimensions may vary according to the intended purpose of such a lens.

  FIG. 20 depicts another modified form of a kidney-shaped haptic, showing a top view and a sagittal view including preliminary dimensions. 21 and 22 illustrate the function of the haptics of the present invention in place for distance vision and near vision.

  In all of the above design manifestations, the ring also stays within the sac at a distance from the equator, or one ring is at the equator and the other is at a distance to alleviate epithelial cell transfer. , And may be secured to the front and / or rear junctions or legs of such arcuate segments. In such cases, the ring may include a right angle in the area that contacts the anterior or posterior surface of the sac. The function of such a ring in conjunction with an arcuate segment may also hold the opening of the capsular bag away from the equator in order to prepare for continuous cleaning of the area by the normal circulation mechanism of the aqueous humor. This may maintain the natural harmony and elasticity of the capsular bag, thus ensuring the extended function of the lens haptics of the present invention.

  FIG. 23 depicts both a top view and a sagittal view of a fully circular haptic with a ribbon and struts that create an oval opening between the optic and the haptic ring. The number of ellipses included and the exact structure of such ellipses may vary according to the intended design of the haptics of the present invention.

  FIG. 24 depicts both a top view and a sagittal view of a complete circular haptic with an arcuate groove of material removed to provide for focus flexibility and fluid flow. In this case, the number of grooves and the length and structure of such grooves may vary according to the intended purpose of the specified haptic.

  Other embodiments and uses of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. All references cited herein, including all literature, US and foreign patents, and patent applications, are specifically and entirely incorporated by reference. The term comprising is intended to include the term consisting of, and consisting essentially of, wherever used. Further, the terms including, including, and containing are not intended to be limiting. It is intended that the specification and examples be considered as exemplary only in the true scope and spirit of the invention as indicated by the following claims.

Claims (35)

  1. A single annular ribbon configured to be placed within the lens capsule of the eye;
    A plurality of struts for directly and coaxially connecting the annular ribbon to the outer periphery of a single lens at a distance from the outer periphery of the lens, and between the annular ribbon and the outer periphery of the lens, A plurality of struts defining openings each having a radial width smaller than the directional length;
    Comprising
    The annular ribbon includes a front haptic ring and a rear haptic ring connected at the apex of a U-shaped recess on the outer peripheral surface of the annular ribbon,
    The posterior haptic ring is an intraocular lens haptic joined at the back to the anterior haptic ring .
  2. The haptic of claim 1, wherein an angle between the plurality of struts is 60 degrees.
  3. The haptic of claim 1, wherein an angle between the plurality of struts is 72 °.
  4. The haptic of claim 1, wherein the plurality of struts define an oval opening between the lens and the annular ribbon.
  5. The haptic of claim 1, wherein the annular ribbon has an inner radius that is greater than an outer radius of the lens.
  6. The haptic of claim 5, wherein each of the plurality of struts connects a point on the outer diameter of the lens to a point on the inner diameter of the front haptic ring.
  7. The haptic of claim 1 , wherein the annular ring is kidney-shaped.
  8. It said annular ring is at least partially solid, haptic of claim 7.
  9. 9. A haptic according to claim 8 , wherein the annular ring has the rigid portion thinner than the rest of the haptic.
  10. The haptic of claim 9, wherein the strut is flexible and bendable.
  11. Compression allows der Ru by instrument to allow for insertion into the eye, the haptic of claim 1.
  12. Outer part of the haptics are compressed into a shape Tsu pointed tip help to enter into the mobile and eye through the syringe, the haptic of claim 11.
  13. The haptic according to claim 1 , wherein the number of the support columns is 5 or more.
  14. The haptic of claim 1 , wherein the number of struts is less than five.
  15. The haptic according to claim 1, further comprising a relaxation material that is provided between the plurality of struts and reduces a mass of each strut.
  16. Structure of the front and rear of the haptic ring comprises a greater angle than 90 ° in contact haptic against嚢表surface so as to suppress the transfer of epithelial cells, the haptic of claim 1.
  17. The haptic according to claim 16 , wherein the contact presents an arc instead of a corner .
  18. The haptic of claim 1, wherein the haptic ring is positionable forward or backward within a sac.
  19. The haptic of claim 4, having five of the oval openings.
  20. The haptic of claim 1, wherein the front haptic ring is disposed forward relative to the front surface of the lens.
  21. The haptic of claim 1, wherein the distal end of the haptic stops at the equator of the sac when placed in the eye.
  22. The haptic of claim 1, wherein the annular ribbon is operable in response to movement of the ciliary protrusion when placed in the eye.
  23. 23. A haptic according to claim 22, wherein movement of the annular ribbon provides focusing.
  24. When placed in the eye, first Nde further including constituted a second haptic to be 180 ° localized relative to the haptic, the haptic of claim 1.
  25. The haptic of claim 1, wherein the lens and haptic are in substantially the same anterior-posterior plane.
  26. 26. The haptic of claim 25 , wherein the forward movement of the lens allows viewing a near object from a single focal plane lens.
  27. The lens is positioned forward relative to the distal end of the positive fornix to form formed haptic, the haptic of claim 25.
  28. The lens is positioned rearward with respect to the distal end of the haptic that form the negative fornix haptic of claim 27.
  29. A part of the haptic has an arcuate portion that is flexible and acts against the rigid part of the haptic that produces an upward force vector, where the ciliary body of the human eye transmits the force. moves the record emission's forward of claim 28 haptics.
  30. When placed in the eye, haptics, as compared with no the haptic intraocular lens, the cellular import from the equator region of the capsule causes a low reduction, according to claim 1 haptic.
  31. And angle of negative fornix, and the radius of the angle between the prime meridian and the lens end equal haptic of claim 25.
  32. The equal angle, to form formed tangent between the edge of capsule and lens contained natural lens, the haptic of claim 31.
  33. Sac is sealed ends of the lens by tangential forces, inhibit cell transfer to the bottom of the lens, the haptic of claim 32.
  34. The haptic of claim 1, wherein the rear haptic ring is a flange extending from the front haptic ring.
  35. The haptic of claim 1, wherein the posterior haptic ring is posteriorly coupled to the anterior haptic ring before and after insertion into the eye.
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US18465509P true 2009-06-05 2009-06-05
US61/184,655 2009-06-05
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US9439755B2 (en) 2016-09-13
EP2361060A4 (en) 2014-02-26
WO2010062976A1 (en) 2010-06-03
AU2009319753B2 (en) 2013-11-14
BRPI0921396A2 (en) 2015-12-29
AU2009319753A1 (en) 2011-06-23
CA2744859A1 (en) 2010-06-03
CA2744859C (en) 2015-11-24
JP2012509751A (en) 2012-04-26
US20100131061A1 (en) 2010-05-27
CN102292051A (en) 2011-12-21
MX2011005583A (en) 2011-10-11

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